Information Technology Equipment
Revision B
Introduction: Responsibility of the Manufacturer
The hardware components supplied by GE for the MARS
analysis workstation, on which the SEER Light Connect application
runs, are considered to be Information Technology Equipment (ITE).
These individual components have been found to comply with the
standard for Safety of Information Technology Equipment, including
Electrical Business Equipment EN60950 (UL 60950).
The software used in the MARS
considered as medical software. The software has been designed and
manufactured to the appropriate medical regulations and controls.
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In order for the MARS
medical equipment standard leakage current requirements, a medical
grade uninterruptible power supply (UPS) must be used (UL 60601-1,
CSA 22.2 No. 60601-1, EN 60601-1) to power all non-medical equipment.
In addition, non-medical electrical equipment must comply with IEC and
ISO safety standards that are relevant to that equipment (i.e., IEC
60950, Safety of Information Technology Equipment.)
SEER Light Ambulatory Recorder/Controller
2019818-008
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Holter analysis workstation is
Holter analysis workstation to comply with
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Holter
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